First QIDP drug approved, but designation may fail urgent needs

Kevin Outterson, School of Law

The problem of ineffective antibiotics is no longer just theoretical. These days, nearly 50,000 people in the US and Europe die each year as a result of antibimicrobial-resistant infections. To reduce this grim toll, in 2012 the US Food and Drug Administration (FDA) began offering the qualified infectious disease product (QIDP) designation, which allows for expedited review and five extra years of market exclusivity for antimicrobials designed to treat serious and life-threatening infections…

Expert quote:

“QIDP probably had very little to do with the ten-year history of the antibiotics in development right now. A decade from now, we will have 15–20 products,” he says, “and few will be what we were hoping for.”

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